SDS Number 110561 Approved/Revised 14-Jul-2008 Version 11
IMITREX NASAL SPRAY
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material IMITREX NASAL SPRAY
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IMITREX NASAL SPRAY 5 MG * IMITREX NASAL SPRAY 20 MG * IMITREX INTRANASAL
Synonym(s)
* IMIGRAN NASAL SPRAY * IMIGRAN INTRANASAL * IMIGRAN NASAL NASENSPRAY 20
MG * IMIGRAN NASAL MITE NASENSPRAY 10 MG * IMIGRANE INTRANASAL * NDC NO
0173-0523-00 * NDC NO 0173-0524-00 * SUMATRIPTAN, FORMULATED PRODUCT
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GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
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GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
.
2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
NON-HAZARDOUS INGREDIENTS Unassigned 80 to 95
SUMATRIPTAN BASE 103628-46-2 5 to 20
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Caution - Potent pharmaceutical agent. Exposure might occur via ingestion; skin; eyes.
Health
Possible effects of overexposure in the workplace include: irritation; inflamed nasal cavity;
changes in heart rate; increased blood pressure; dizziness; visual disturbances; weakness;
salivation; headache; feelings of heaviness or pressure; tingling; drowsiness; flushing;
fatigue.
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Dangerous for the environment. Harmful to aquatic organisms. May cause long-term adverse
Environment
effects in the aquatic environment.
4. FIRST-AID MEASURES
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Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the
exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.
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SDS Number 110561 Approved/Revised 14-Jul-2008 Version 11
IMITREX NASAL SPRAY
Material
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Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
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Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
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Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
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NOTES TO HEALTH PROFESSIONALS
Medical treatment in cases of overexposure should be treated as an overdose of a
Medical Treatment
5-hydroxytryptamine agonist. Treat according to locally accepted protocols. For additional
guidance, refer to the current prescribing information or to the local poison control
information centre.
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None for occupational exposure.
Medical Conditions
Caused or Aggravated by
Exposure
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No specific antidotes are recommended.
Antidotes
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5. FIRE-FIGHTING MEASURES
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This product is non-combustible, although the packaging is combustible.
Fire and Explosion Hazards
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Water is recommended for fires involving packaging.
Extinguishing Media
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For single units (packages): No special requirements needed. For larger amounts (multiple
Special Firefighting
packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved
Procedures
from fires involving this product and associated packaging, self contained breathing
apparatus and full protective equipment are recommended for firefighters. If possible, contain
and collect firefighting water for later disposal.
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Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
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For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
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Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
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No specific decontamination or detoxification procedures have been identified for this
Decontamination Procedures
product.
7. HANDLING AND STORAGE
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HANDLING
No special control measures required for the normal handling of this product. Normal room
General Requirements
ventilation is expected to be adequate for routine handling of this product.
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No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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SUMATRIPTAN BASE
INGREDIENT
3
GSK Occupational Hazard
Category
GSK Occupational 50 mcg/m3 (8 HR TWA)
Exposure Limit 100 mcg/m3 (15 MIN STEL)
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ENGINEERING CONTROLS
Open handling may result in overexposure.
Containment
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Local exhaust ventilation (LEV) should be used in conjunction with other control measures as
Ventilation
a means of removing material incidentally released.
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SDS Number 110561 Approved/Revised 14-Jul-2008 Version 11
IMITREX NASAL SPRAY
Material
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Entry to the working area should be controlled. Only authorised personnel may enter the
Administrative
working area.
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PERSONAL PROTECTIVE EQUIPMENT
Wear approved safety glasses with side shields or cover goggles if eye contact is possible.
Eye Protection
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Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after
Other Equipment or
handling. An eye wash station should be available.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
Solution.
Physical Form
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5.4 to 5.6
pH of Aqueous Solutions
10. STABILITY AND REACTIVITY
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DO NOT FREEZE - dispose of properly if frozen.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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This product contains active ingredient(s) with the following activity: a 5-hydroxytryptamine
Pharmacological Effects
agonist.
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No specific target organ effects have been identified.
Target Organ Effects
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Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
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Overexposure may result in irritation of the respiratory tract.
Inhalation Toxicity
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Irritation is not expected following direct contact.
Skin Effects
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Irritation is not expected following direct contact with eyes.
Eye Effects
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Sensitisation (allergic skin reaction) is not expected.
Sensitisation
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Not expected to be genotoxic under occupational exposure conditions.
Genetic Toxicity
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
Carcinogenicity
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Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions.
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None known for occupational exposure.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
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This product contains an active ingredient that has been tested and which may be harmful if
Summary
released directly to the environment. Appropriate precautions should be taken to limit release
of this material to the environment. Local regulations and procedures should be consulted
prior to environmental release.
Specific information on the active pharmaceutical ingredient which is the majority component
is provided below.
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ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is not
Activated Sludge
toxic to activated sludge microorganisms.
Respiration
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IC50: 536 mg/l, 3 Hours, Activated sludge, Nominal
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This material contains an active pharmaceutical ingredient that is
Algal
harmful to algae.
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IC50: 26 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae, Measured
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NOEC: 8.9 mg/l, 72 Hours, Scenedesmus subspicatus,
green algae, Measured
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SDS Number 110561 Approved/Revised 14-Jul-2008 Version 11
IMITREX NASAL SPRAY
Material
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This material contains an active pharmaceutical ingredient that is not
Daphnid
toxic to daphnids. This material contains an active pharmaceutical
ingredient that is harmful to daphnids in chronic toxicity studies.
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EC50: 206 mg/l, 48 Hours, Daphnia pulex, Measured
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NOEC: 142 mg/l, 48 Hours, Daphnia pulex, Measured
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Chronic LOEC: 71 mg/l, 8 Days, Ceriodaphnia dubia, Static
renewal test
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Chronic NOEC: 23 mg/l, 8 Days
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This material contains an active pharmaceutical ingredient that is not
Fish
toxic to fish.
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Juvenile Salmo gairdneri, rainbow trout
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EC50: > 71 mg/l, 96 Hours, Measured
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Juvenile Salmo gairdneri, rainbow trout
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NOEC: 71 mg/l, 96 Hours, Measured
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has solubility in water.
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This material contains an active pharmaceutical ingredient that will not readily enter into air
Volatility
from water.
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Henrys Law Constant < 9.00E-13 atm m3/mol
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Distribution
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Octanol/Water -2 at pH 5
Distribution Coefficient
(log Dow):
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Octanol/Water -2.3 at pH 7
Distribution Coefficient
(log Dow):
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Octanol/Water -0.5 at pH 9
Distribution Coefficient
(log Dow):
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This material contains an active pharmaceutical ingredient that is likely to adsorb to soil or
Adsorption
sediment. This material contains an active pharmaceutical ingredient that is likely to adsorb
to sludges and other biomass.
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Soil Sediment Sorption 3.52 to 3.57
(log Koc):
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This material contains an active pharmaceutical ingredient with octanol/water partition
Partitioning
coefficient data that suggests that for environmental fate predictions the active
pharmaceutical ingredient will not have the tendency to distribute into fats.
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PERSISTENCE/DEGRADATION
This material contains an active pharmaceutical ingredient that has been shown to be
Hydrolysis
chemically stable in water. Hydrolysis is unlikely to be a significant depletion mechanism.
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This material contains an active pharmaceutical ingredient that is likely to undergo
Photolysis
photodegradation.
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UV/Visible Spectrum: 293 nm at pH 7
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This material contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
but is inherently biodegradable (as defined by 1993 OECD Testing Guidelines) and is not
expected to persist in the environment. This mixture contains an active pharmaceutical
ingredient that slowly undergoes biodegradation in soil.
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Aerobic - Ready
Percent Degradation: 1 %, 28 days
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Aerobic - Inherent
Percent Degradation: 100 %, 28 days, Modified Zahn-Wellens, primary biodegradation,
loss of parent., Activated sludge
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Aerobic - Soil
Percent Degradation: 32.1 to 40.2 %, 64 days
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SDS Number 110561 Approved/Revised 14-Jul-2008 Version 11
IMITREX NASAL SPRAY
Material
13. DISPOSAL CONSIDERATIONS
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Collect for recycling or recovery if possible. The disposal method for rejected
Disposal Recommendations
products/returned goods must ensure that they cannot be re-sold or re-used.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
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The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons
trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous
goods for transport.
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UN Classification and Labelling
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US or
European ground transport purposes.
15. REGULATORY INFORMATION
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The information included below is an overview of the major regulatory requirements. It should not be considered to be an
exhaustive summary. Local regulations should be consulted for additional requirements.
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EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
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US OSHA Standard (29 CFR Part 1910.1200)
This product is classified as hazardous according to the OSHA Hazard Communication
Classification
Standard.
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Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
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GSK Hazard Determination
References
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11
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF
COMPANY
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The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of
issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine
the applicability of this information and the suitability of the material or product for any particular purpose.
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